Amendment to Part 5
38. For Part 5 substitute—
“PART 5Approval of Conformity Assessment Bodies
Approved bodies
53.—(1) An approved body is a conformity assessment body which—
(a)has been approved by the Secretary of State pursuant to the procedure set out in regulation 54 (approval of conformity assessment bodies); or
(b)immediately before exit day was a notified body in respect of which the Secretary of State had taken no action under regulation 60(1) or (2) as they had effect immediately before exit day to suspend or withdraw the body’s status as a notified body.
(2) Paragraph (1) has effect subject to regulation 57 (restriction, suspension or withdrawal of approval).
(3) In this Part—
“notified body” means a body—
which the Secretary of State had before exit day notified to the European Commission and the member States of the European Union, in accordance with Article 23 of the Directive; and
in respect of which no objections had been raised, as referred to in regulation 53(2)(b), as it had effect immediately before exit day;
“approved body requirements” means the requirements set out in Schedule 5.
Approval of conformity assessment bodies
54.—(1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval.
(2) A conformity assessment body qualifies for approval if the first and second conditions below are met.
(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—
(a)a description of—
(i)the conformity assessment activities that the conformity assessment body intends to carry out;
(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; and
(iii)the regulated measuring instrument for which the conformity assessment body claims to be competent; and
(b)either—
(i)an accreditation certificate; or
(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body’s compliance with the approved body requirements.
(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.
(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b)(i), as sufficient evidence that the conformity assessment body meets the approved body requirements.
(6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may–
(a)have regard to any other matter which appears to the Secretary of State to be relevant; and
(b)set conditions that the conformity assessment body must meet.
(7) For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.
Presumption of conformity of approved bodies
55.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard).
(2) The presumption in paragraph (1) is rebuttable.
Monitoring
56. The Secretary of State must monitor each approved body with a view to verifying that the body—
(a)continues to meet the approved body requirements;
(b)meets any conditions set—
(i)in accordance with regulation 54(6)(b); or
(ii)in the case of an approved body which was a notified body immediately before exit day, in accordance with regulation 54(6)(b) as it applied immediately before exit day; and
(c)carries out its functions in accordance with these Regulations.
Restriction, suspension or withdrawal of approval
57.—(1) Where the Secretary of State determines that an approved body—
(a)no longer meets an approved body requirement, or
(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 54(6)(b),
the Secretary of State must restrict, suspend or withdraw the body’s status as an approved body under regulation 54 (approval of conformity assessment bodies).
(2) With the consent of an approved body, or where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 56(b), the Secretary of State may restrict, suspend or withdraw the body’s status as an approved body under regulation 54 (approval of conformity assessment bodies).
(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.
(4) Before taking action under paragraph (1) or (2), the Secretary of State must—
(a)give notice in writing to the approved body of the proposed action and the reasons for it;
(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and
(c)consider any such representations made by the approved body.
(5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must—
(a)on the request of the Secretary of State, transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or
(b)in the absence of a request under sub-paragraph (a), ensure that its files relating to the activities it has undertaken as an approved body are kept available for the Secretary of State and competent authorities for a period of 10 years from the date they were created.
(6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body.
(7) The Secretary of State may impose a monetary penalty on an approved body that fails to comply with any requirement imposed by or under paragraph (5).
(8) Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (7).
Register of approved bodies
58.—(1) The Secretary of State must—
(a)assign an approved body identification number to each approved body; and
(b)compile and maintain a register of—
(i)approved bodies;
(ii)their approved body identification numbers;
(iii)the activities for which they have been approved; and
(iv)any restrictions on those activities.
(2) The register referred to in paragraph (1) must be made publicly available.
UK national accreditation body
59.—(1) The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—
(a)assessing whether a conformity assessment body meets the approved body requirements; and
(b)monitoring approved bodies in accordance with regulation 56;
(2) Where the Secretary of State authorises the UK national accreditation body pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.”.